Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-06 @ 2:32 AM
Study NCT ID:
NCT04059159
Status:
TERMINATED
Last Update Posted:
2023-01-20
First Post:
2019-08-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Connected Catheter - Safety and Effectiveness Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}, {'id': 'D016055', 'term': 'Urinary Retention'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dherrera@urodevmedical.com', 'phone': '949-436-7974', 'title': 'Derek Herrera', 'organization': 'Spinal Singularity'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'single arm, small sample size'}}, 'adverseEventsModule': {'timeFrame': 'From initial catheter insertion through study completion, which was up to 7 weeks.', 'description': 'There are no significant differences in the definitions and requirements for adverse event reporting.', 'eventGroups': [{'id': 'EG000', 'title': 'Connected Catheter Users', 'description': 'Connected Catheter: Patients will use the Connected Catheter to empty the bladder during the course of treatment.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Device Related Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Connected Catheter Users', 'description': 'Connected Catheter: Patients will use the Connected Catheter to empty the bladder during the course of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 - 49 days', 'description': 'Rate of participants treated with the Connected Catheter reported with a serious device related adverse event', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This is based on the number of patients who had catheter insertion attempted.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With UTI (Occurrence Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Connected Catheter Users', 'description': 'Connected Catheter: Patients will use the Connected Catheter to empty the bladder during the course of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 - 49 days', 'description': 'Rate of participants treated with the Connected Catheter reported with a symptomatic urinary tract infection', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This is based on the number of patients who had catheter insertion attempted.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Lower Urinary Tract Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Connected Catheter Users', 'description': 'Connected Catheter: Patients will use the Connected Catheter to empty the bladder during the course of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 - 40 days', 'description': 'Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This is based on the number of patients who had catheter insertion attempted.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Connected Catheter Users', 'description': 'Connected Catheter: Patients will use the Connected Catheter to empty the bladder during the course of treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Connected Catheter Users', 'description': 'Connected Catheter: Patients will use the Connected Catheter to empty the bladder during the course of treatment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.4', 'spread': '10.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Other, Unknown or Not Reported', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '166.8', 'spread': '33.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'lbs', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ambulatory Status', 'classes': [{'title': 'Fully Ambulatory', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Partially Ambulatory', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Non-Ambulatory', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-01', 'size': 1485718, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-29T13:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'The investigation of this device has been transitioned into a new study by the sponsor. The data generated in this study will not be used to support a marketing application', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-28', 'studyFirstSubmitDate': '2019-08-14', 'resultsFirstSubmitDate': '2022-11-29', 'studyFirstSubmitQcDate': '2019-08-14', 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-28', 'studyFirstPostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Device Related Serious Adverse Events', 'timeFrame': '0 - 49 days', 'description': 'Rate of participants treated with the Connected Catheter reported with a serious device related adverse event'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With UTI (Occurrence Rate)', 'timeFrame': '0 - 49 days', 'description': 'Rate of participants treated with the Connected Catheter reported with a symptomatic urinary tract infection'}, {'measure': 'Number of Participants With Lower Urinary Tract Injury', 'timeFrame': '0 - 40 days', 'description': 'Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['catheter', 'Spinal Cord Injury (SCI)'], 'conditions': ['Neurogenic Bladder', 'Urinary Retention', 'Urologic Diseases']}, 'descriptionModule': {'briefSummary': 'The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. It is a sterile, extended-use device that resides fully internally to the male lower urinary tract for an intended use life of up to 7 days per catheter.', 'detailedDescription': 'Spinal Singularity has developed the Connected Catheter System to address several drawbacks of urinary catheters. The Connected Catheter is fully internal, indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. Each subject will use the Connected Catheter for up to 35-40 days. This includes five device exchange appointments. The appointments are spaced 7 days apart and at each appointment the catheter will be replaced with a new one. Additionally, weekly follow-up will occur for 14 days following the final appointment after the subject discontinues use of study device and reverts to his original catheter.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Device is currently only designed for use by males.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males age ≥ 18 with clinical diagnosis of significant urinary retention\n2. Must be clinically suitable and capable of safely managing bladder using an intermittent voiding or indwelling strategy\n\n 1. Must have stable urinary management history as determined by the investigator OR:\n 2. Must have urodynamic profile suitable for Gen 2 Connected Catheter (including bladder capacity \\> 200mL without uninhibited bladder contractions)\n3. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the Gen 2 Connected Catheter device, as specified in the Investigational Device Instructions for Use (IFU).\n\nExclusion Criteria:\n\n1. Active symptomatic urinary tract infection, as defined in this clinical investigation protocol (subjects may receive the device after UTI has been treated)\n2. Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 days)\n3. Significant risk profile or recent history of clinically significant (uncontrolled) autonomic dysreflexia\n4. Significant intermittent urinary incontinence (between catheterizations)\n5. Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably controlled with medication or alternate therapy (e.g. Botox injection)\n6. Pre-existing urinary pathologies and/or morphological abnormalities of the lower urinary tract or bladder (assessed during in-depth medical screening, including cystoscopy and urine analysis)\n\n 1. Urinary tract inflammation or neoplasm\n 2. Urinary fistula\n 3. Bladder diverticulum (outpouching) \\> 5cm in size\n 4. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 months)\n 5. Impaired kidney function or renal failure\n 6. Active gross hematuria\n 7. Active urethritis\n7. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted drug pump) or external device\n8. Any unsuitable comorbidities as determined by the Investigator or complications related to use of certain medications\n9. Any physical or cognitive impairments that diminish the subject's ability to follow directions or otherwise safely use the Gen 2 Connected Catheter System\n10. Catheter Assessment Tool screening yields unacceptable results"}, 'identificationModule': {'nctId': 'NCT04059159', 'briefTitle': 'Connected Catheter - Safety and Effectiveness Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spinal Singularity'}, 'officialTitle': 'Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention', 'orgStudyIdInfo': {'id': 'CIP-0002 (formerly ES-NIH-01)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Connected Catheter Users', 'interventionNames': ['Device: Connected Catheter']}], 'interventions': [{'name': 'Connected Catheter', 'type': 'DEVICE', 'description': 'Patients will use the Connected Catheter to empty the bladder during the course of treatment.', 'armGroupLabels': ['Connected Catheter Users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Rancho Los Amigos Rehabiliation Hospital', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar National Rehabilitation Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spinal Singularity', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}